Devices and methods for stenting an airway

ABSTRACT

An implantable device and method are disclosed for stenting an occlusion of an airway. The implantable device includes a cylindrical tube shaped proximal region, a flared distal region, and a non-bifurcated single lumen extending through the device. The proximal region defines a proximal portion of the lumen and the distal region defines a distal portion of the lumen. The distal region may flare outward laterally at a first angle and anteroposterior at a second angle, thereby forming an elliptically shaped distal opening to the lumen. The distal edge of distal opening may lie entirely in a plane orthogonal to a longitudinal axis of the device. Alternatively, the distal edge may be non-planar, such as concave or convex, when viewed in an anteroposterior direction. The implantable device may be formed of a scaffolding structure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. §119(e) of U.S.Provisional Patent Application No. 61/549,874, entitled “CARINAL STENT,”filed Oct. 21, 2011, which is hereby incorporated herein by reference inits entirety.

TECHNICAL FIELD

The present disclosure relates generally to devices configured to beimplanted within a body lumen. More particularly, the present disclosurerelates to stents or similar prosthetic devices which, in certainembodiments, are configured to be disposed within an airway lumen,specifically, at a bifurcation of the airway lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

The written disclosure herein describes illustrative embodiments thatare non-limiting and non-exhaustive. Reference is made to certain ofsuch illustrative embodiments that are depicted in the figures, inwhich:

FIG. 1 is a diagram of the human lungs and principle parts of theairway.

FIG. 2 is a cross-sectional view of the trachea looking distally to thecarina and the right principal bronchus and the main left bronchus.

FIG. 3A is a side elevation view of an airway stent, according to oneembodiment of the present disclosure that may be positioned at the mainbifurcation junction of the airway, at or near the carinal region of thetrachea.

FIG. 3B is a perspective view of the airway stent of FIG. 3A.

FIG. 3C is a cross-sectional distal-facing view of the airway stent ofFIG. 3A.

FIG. 3D is a cross-sectional proximal-facing view of the airway stent ofFIG. 3A.

FIG. 3E is another cross-sectional proximal-facing view of the airwaystent of FIG. 3A.

FIG. 3F is another perspective view of the airway stent of FIG. 3A.

FIG. 4A is a partial sectional view of the human lungs with the airwaystent of FIGS. 3A-3F positioned at the main bifurcation junction.

FIG. 4B is a partial sectional view of the human lungs with an airwaystent, according to one embodiment, positioned at a bifurcation junctionof the left main bronchus.

FIG. 4C is a partial sectional view of the human lungs with an airwaystent, according to one embodiment, positioned in the airway at aposition distal to the left main bronchus.

FIG. 5A is a side elevation view of an airway stent, according toanother embodiment of the present disclosure.

FIG. 5B is a perspective view of the airway stent of FIG. 5A.

FIG. 5C is another perspective view of the airway stent of FIG. 5A.

FIG. 6 is a partial sectional view of the airway stent of FIGS. 5A-5Cpositioned in an airway at the main bifurcation junction.

FIG. 7A is a side elevation view of an airway stent, according toanother embodiment of the present disclosure.

FIG. 7B is a perspective view of the airway stent of FIG. 7A.

FIG. 7C is another perspective view of the airway stent of FIG. 7A.

FIG. 8 is a partial sectional view of the airway stent of FIGS. 7A-7Cpositioned in an airway at the main bifurcation junction.

FIG. 9A is a side elevation view of an airway stent, according toanother embodiment of the present disclosure.

FIG. 9B is a perspective view of the airway stent of FIG. 9A.

FIG. 9C is another perspective view of the airway stent of FIG. 9A.

FIG. 9D is an end view of the airway stent of FIG. 9A.

FIG. 10 is a partial sectional view of the airway stent of FIGS. 9A-9Dpositioned in an airway at the main bifurcation junction.

DETAILED DESCRIPTION

Tracheo-bronchial (or “airway”) stenting is more and more commonlyperformed to relieve difficult or labored breathing caused by a varietyof conditions, including but not limited to extrinsic and/or intrinsiccompression (e.g., stenosis), disease, and loss of cartilaginoussupport. Airway stenting can relieve airway obstruction caused bystrictures, injury, disease, or the like that may not suitably beresolved by debridement, resection, reconstruction or the like. Airwaystenting can also provide structural support for an airway structurallydamaged through repairing an obstruction, such as by debridement,resection, or reconstruction.

In particular, stents are used in tumor patients, to ensure that therespiratory tract is kept open when the risk exists that the trachea maybe compressed by a tumor. Stents are also used for stabilization of theairway in the context of tissue distension (malacia), or to seal offdefects in the tracheal or bronchial walls (fistulae).

Because of the anatomic structure, airway stenting can be extremelydifficult when an obstruction or structural failure of the airwayinvolves the carinal region (the main bifurcation junction between theopenings of the right and left principal bronchi) or another, moredistal, bifurcation junction where the airway branches. The anatomy orstructure of a bifurcation junction is not readily supported by atypical cylindrical stent. A bifurcation junction is not easily stentedwith a cylindrical stent because the cylindrical shape can result inpartial occlusion of the branches. Similarly the branches create flaringor expansion of the airway, allowing instability in the positioning ofthe stent. A cylindrical stent can shift within the expanded area of thebifurcation junction and migrate down one of the branches, therebypartially or entirely occluding the other branch.

Though many of the examples provided herein refer to stents configuredfor use within the airway, the present disclosure is also applicable toa variety of stents designed for a variety of applications in variouslumens of the body.

It will be readily understood with the aid of the present disclosurethat the components of the embodiments, as generally described andillustrated in the figures herein, could be arranged and designed in avariety of configurations. Thus, the following more detailed descriptionof various embodiments, as represented in the figures, is not intendedto limit the scope of the disclosure, but is merely representative ofvarious embodiments. While the various aspects of the embodiments arepresented in drawings, the drawings are not necessarily drawn to scaleunless specifically indicated.

The phrases “connected to,” “coupled to,” and “in communication with”refer to any form of interaction between two or more entities, includingbut not limited to mechanical, electrical, magnetic, electromagnetic,fluid, and thermal interaction. Two components may be coupled to eachother even though they are not in direct contact with each other. Forexample, two components may be coupled to each other through anintermediate component.

The terms “proximal” and “distal” refer to opposite ends of a medicaldevice, including the implantable devices disclosed herein. As usedherein, the proximal end of a medical device is the end nearest apractitioner during use, while the distal end is the opposite end. Forexample, the proximal end of a stent refers to the end nearest thepractitioner when the stent is disposed within, or being deployed from,a deployment apparatus. For consistency throughout, these terms remainconstant in the case of a deployed stent, regardless of the orientationof the stent within the body. In the case of an airway stent—deployedthrough the mouth of a patient—the proximal end will be nearer the headof the patient and the distal end nearer the abdomen (or deeper into thelungs) when the stent is in a deployed position.

FIG. 1 is a diagram of the human lungs 100. The trachea 102 branchesinto the right principal bronchus 104 and the left principal bronchus106. The bronchus 104, 106 in turn branch into bronchi 108, which inturn branch into bronchioles 110 and terminate at alveoli 112. Thecarina 114 of the trachea 102 is a cartilaginous ridge that runsanteroposteriorly at a first and main bifurcation junction 103 of theairway between the right principal bronchus 104 and the left principalbronchus 106. More distal (i.e., deeper into the lungs) bifurcationjunctions, such as a bifurcation 105 of the right principal bronchus 104(or right bronchus bifurcation junction 105) and the bifurcation 107 ofthe left principal bronchus 106 (or left bronchus bifurcation junction107), may also include a cartilaginous ridge-like structure that issimilar to the carina 114. FIG. 2 is a cross-sectional view of the mainbifurcation junction 103, looking down the trachea 102 (i.e., distally,or deeper into the lungs) at the carina 114 and the right principalbronchus 104 and the left principal bronchus 106. The bronch±108 of theright principal bronchus 104 are also illustrated.

Traditionally a Y-shaped stent has been used in bifurcation junctions ofthe airway. A Y-shaped stent can be inadequate because, among otherthings, it may not conform to the anatomy of the patient. For example,the angles of the branches of the stent may differ from the angles ofthe principal bronchi 104, 106 or other more distal airway branches.Also, the diameter of the branches of the stent may be smaller than thediameter of the respective airway branches. The greater the differencesof the stent from the anatomy of the patient, the greater the chance fordiscomfort or even pain (e.g., the branches of the stent applyingpressure to the sidewall of the bronchi or altering the positioning ofthe bronchi) and for partial or complete obstruction of the airway(e.g., a stent with a diameter that may be too small will unavoidablyfunction as an obstruction of at least a portion of the airway andreduce airflow). The present disclosure provides novel systems andmethods for stenting bifurcation junctions of the airway, including themain bifurcation junction 103, the bronchus bifurcation junctions 105,107, and more distal bifurcation junctions such as bifurcation junctionsof the bronchi 108 and/or bronchioles 110.

Embodiments may be best understood by reference to the drawings, whereinlike parts are designated by like numerals throughout. It will bereadily understood that the components of the present disclosure, asgenerally described and illustrated in the drawings herein, could bearranged and designed in a wide variety of different configurations.Thus, the following more detailed description of the embodiments of theapparatus is not intended to limit the scope of the disclosure, but ismerely representative of possible embodiments of the disclosure. In somecases, well-known structures, materials, or operations are not shown ordescribed in detail.

FIGS. 3A-3F are an airway stent 300 according to one embodiment of thepresent disclosure. FIG. 3A is a side elevation view of the airway stent300, providing an anteroposterior view of the airway stent 300. FIG. 3Bis a perspective view of the airway stent 300. FIG. 3C is across-sectional distal-facing view of the airway stent 300. FIG. 3D is across-sectional proximal-facing view of the airway stent 300. FIG. 3E isanother cross-sectional proximal-facing view of the airway stent 300.FIG. 3F is another perspective view of the airway stent 300.

The airway stent 300 may be an implantable device configured forplacement in a lumen of an airway to treat, for example, a stricture,closure, blockage or occlusion of the airway. The airway stent 300 maybe configured to resist stricture and otherwise function to maintainpatency of the airway. Additionally, the stent 300 may comprise avariety of components, and the parameters of these components (e.g.,shape, length, thickness, position, etc.) may be configured to providethe stent 300 with certain properties. For example, the stent 300 may beconfigured to distribute transverse loads or to change shape in responseto certain forces.

Referring collectively to FIGS. 3A-3F, the airway stent 300 may beformed of a suitable material configured in a scaffolding structure 301(only partially depicted for simplicity) or mesh and formed into a tubehaving a substantially cylindrical shape (although one or morecross-sectional diameters of the tube may vary independently as will bedescribed below). The scaffolding structure 301 may be constructed of amemory material, such as Nitinol®, including ASTM F2063.

The thickness of the scaffolding structure 301 may be between about 0.30mm and about 0.60 mm. In other embodiments, the thickness of thescaffolding structure 301 may be between about 0.35 mm and about 0.55mm. In other embodiments, the thickness of the scaffolding structure 301may be between about 0.40 mm and about 0.50 mm. In other embodiments,the thickness of the scaffolding structure 301 may be about 0.45 mm.

As illustrated best in FIG. 3A, the scaffolding structure 301 may beformed of multiple annular segments 322 (or rings) disposed on acircumference and defining at least a portion of the generallycylindrical shape of the scaffolding structure 301. Each annular segment322 may comprise a plurality of interconnected strut arms 324. Forexample, the strut arms 324 may be connected such that they form azigzag pattern, defining alternating “peaks” and “valleys,” around theannular segment 322. (As used herein, “peaks” refer to the relative highpoints and “valleys” refer to the relative low points where strut arms324 arranged in a zigzag pattern connect. In other words, the peaks andvalleys may be relative to one end 306, 308 of the stent 300, ratherthan relative to the circumference of the stent 300.) In someembodiments adjacent strut arms 324 may form acute angles relative toeach other.

The adjacent annular segments 322 may be arranged in rows around alongitudinal axis A_(L) of the generally cylindrical shape of thescaffolding structure 301. The rows may be arranged in the longitudinaldirection of the generally cylindrical shape of the scaffoldingstructure 301. Adjacent annular segments 322 may be coupled to eachother by connectors 326.

The components and elements of the scaffolding structure 301, includingthe annular segments 322, the strut arms 324, and the connectors 326,may be configured to balance transverse forces applied to thescaffolding structure 301, for example, to reduce the incidence ofinfolding. The components and elements of the scaffolding structure 301may be configured to allow at least a portion of the scaffoldingstructure 301 to decrease in diameter in response to an axial forceapplied to the scaffolding structure 301, for example to enablesheathing of the stent 300 in a deployment device and/or retrieval ofthe stent 300.

Some example embodiments of a scaffolding structure 301 are disclosed inU.S. patent application Ser. No. 10/288,615 (issued as U.S. Pat. No.7,527,644) and U.S. patent application Ser. No. 13/285,358, which arehereby incorporated herein by reference in their entirety.

In the figures, only portions of the scaffolding structure 301 areshown, for simplicity. As will be appreciated, the entire stent 300 maybe defined by an integrally formed scaffolding structure 301. In otherembodiments, the scaffolding structure 301 may form merely a portion ofthe stent 300, such as all or a portion of a proximal region 302 (or amid-body) and/or all or a portion of a distal region 304 (or a flaredregion), and other portions of the stent 300 may be formed by anotherstructure and/or material, such a woven Nitinol wire mesh that may becoupled to the laser cut scaffolding structure 301 through a winding orweaving process.

The scaffolding structure 301 may be coated, or otherwise be enclosed ina cover 340 formed of a flexible material. The cover 340 may beelastomeric, polymeric, or comprised of any other material known in theart. In some embodiments, the cover 340 may include polyurethane, whilein certain embodiments the cover may be comprised only of polyurethane.In some embodiments, the cover 340 may include silicone, while incertain embodiments the cover may be comprised only of silicone. In someembodiments, an internal surface of the cover may be coated with ahydrophilic layer. Some example embodiments of coverings are disclosedin U.S. patent application Ser. No. 10/669,450 (issued as U.S. Pat. No.7,637,942), U.S. patent application Ser. No, 10/718,217 (issued as U.S.Pat. No. 7,959,671), and U.S. patent application Ser. No. 12/616,455(issued as U.S. Pat. No. 8,206,436), all of which are herebyincorporated herein by reference in their entirety.

The airway stent 300 may comprise a proximal region 302 (or a mid-body)and a distal region 304 (or a flared region). The distal region 304 maybe at a distal end 308 of the proximal region 302. A non-bifurcatedsingle lumen 330 extends axially through the stent 300 along alongitudinal axis A_(L) of the stent 300. The airway stent 300 isconfigured such that a proximal end 306 of the proximal region 302 canbe positioned in a portion of the airway and a distal end 308, includingthe distal region 304, can be positioned in a bifurcation junction ofthe airway. For example, the proximal end 306 may be positioned in thetrachea 102 (FIG. 1) and the distal region 304 can be positioned in themain bifurcation junction 103 (FIGS. 1 and 2) at the carinal region, asshown, for example in FIG. 4. The airway stent 300 may have an anteriorside 310, a posterior side 312, a left side 314, and a right side 316(see FIG. 3C). In some embodiments, the airway stent 300 may have aspecific orientation when disposed in the airway. In other words, theairway stent 300 may only fit in the target bifurcation junctionoriented a certain way.

The proximal region 302 may have a hollow substantially cylindricalshape. Particularly at or near the proximal end 306, the shape of theproximal region 302 may be substantially cylindrical. The proximalregion 302 may be hollow to define a portion of a lumen 330 through thestent 300. The lumen 330 may extend axially along a longitudinal axisA_(L) of both the cylindrical shape of the proximal region 302 and thestent 300 from a first opening 332 at the proximal end 306 of the stent300 to a second opening 334 at the distal end 308 of the stent 300. Across-section of the proximal region 302 may be substantially circular,particularly at the proximal end 306. The circular cross-section of theproximal region 302 is shown in FIG. 3D. The first opening 332 may becircular. A transverse cross-section of the proximal region 302 and thelumen 330 at a distal end of the proximal region 302 may be circular orapproximately circular. Described differently, a diameter D1 of theproximal region 302 extending from the anterior side 310 to theposterior side 312 (an anteroposterior diameter) may be substantiallythe same as a diameter D2 of the proximal region 302 extending from theleft side 314 to the right side 316 (a lateral diameter). For example,in one embodiment, the airway stent 300 may be designed and configuredfor placement in the trachea 102 (see FIG. 1) and may have across-sectional diameter D1, D2 of the proximal region 302 that isbetween approximately fourteen millimeters and twenty-two millimeters.In another embodiment, the airway stent 300 may be designed andconfigured for placement in a bronchial portion of the airway (e.g., inthe bronchi 108 shown in FIG. 1). An airway stent 300 configured forplacement in the left main bronchus 106, the cross-sectional diameterD1, D2 of the proximal region 302 may between approximately sixmillimeters and sixteen millimeters. As can be appreciated, in an airwaystent 300 configured for placement in the bronchioles, the diameter D1,D2 of the proximal region 302 may be smaller.

In other embodiments, the cross-sectional shape of the proximal region302 and/or the lumen 330 may vary along the length L1 of the stent 300,for example to conform to the shape and/or features of the airway.

The length L1 of the proximal region 302 can vary as appropriate toprovide desired stenting support and/or to conform to patient anatomy.For example, an airway stent 300 configured for placement in the trachea102, to stent the main bifurcation junction 103 (see FIGS. 1 and 2), mayhave a proximal region 302 with a length L1 that is betweenapproximately thirty millimeters and ninety millimeters. An airway stent300 configured for placement in a bronchial portion of the airway (e.g.,in the bronch±108 of FIGS. 1 and 2) may have a proximal region 302 witha length L1 that is between approximately fifteen millimeters and fiftymillimeters. As can be appreciated, in an airway stent 300 configuredfor placement in the bronchioles, the length L1 of the proximal region302 may be smaller.

The distal region 304 is positioned at the distal end 308 of the stent300 and/or the proximal region 302. A proximal end of the distal region304 couples to and conforms to a circumference of a distal end of theproximal region 302. The distal region 304 may be configured to flaredistally and outwardly to substantially conform to the anatomy of abifurcation junction. The distal region 304 may define a distal portionof the lumen 330 through the stent 300 and a second opening 334 into thelumen 330. An airway bifurcation junction, such as the main bifurcationjunction 103 near the carinal region, naturally flares. However, theanteroposterior diameter of the airway in a bifurcation junction may notflare to the same degree as the lateral diameter of the airway. Thelateral diameter may typically flare to a greater degree than theanteroposterior diameter. Accordingly, a cross-section of the distalregion 304 of the stent 300 may have a substantially elliptical shape,having a greater lateral diameter D2 than an anteroposterior diameterD1, as shown in FIGS. 3C and 3E. (The anteroposterior diameter D1 andthe lateral diameter D2 may be transverse to and may intersect thelongitudinal axis A_(L) of the stent 300 and may also be referred toherein as first and second diameters, respectively.) For example, anairway stent 300 configured for placement in the trachea 102, to stentthe main bifurcation junction 103 (see FIGS. 1 and 2), may have a distalregion 304 with an anteroposterior diameter D1 at the edge 320 of thedistal region 304 that is between approximately fourteen millimeters andtwenty-two millimeters and a lateral diameter D2 at the edge 320 of thedistal region 304 that is between approximately nineteen millimeters andthirty-two millimeters. An airway stent 300 configured for placement ina bronchial portion of the airway (e.g., in the bronchi 108) may have adistal region 304 with an anteroposterior diameter D1 at the edge 320 ofthe distal region 304 that is between approximately six millimeters andsixteen millimeters and a lateral diameter D2 that is betweenapproximately twelve millimeters and twenty-eight millimeters. As can beappreciated, in an airway stent 300 configured for placement in thebronchioles, the diameter D1, D2 of the distal region 302 may besmaller.

The degree or angle at which the anteroposterior diameter D1 and thelateral diameter D2 may flare can vary. Differing degrees of flaring arepossible, and can be configured independently as desired according tothe anatomy of a patient. Stated differently, an angle A1 at which thedistal region 304 flares anteroposteriorly can vary independently fromthe angle A2 at which the distal region 304 flares laterally.

A length L2 of the distal region 304 can vary, for example, to providedesired stenting support and according to patient anatomy. As anexample, an airway stent 300 configured for placement in the trachea102, to stent the main bifurcation junction 103 (see FIGS. 1 and 2), mayhave a distal region 304 with a length L2 that is between approximatelyfive millimeters and fifteen millimeters. An airway stent 300 configuredfor placement in a bronchial portion of the airway (e.g., in the bronchi108) may have a distal region 304 with a length L2 that is betweenapproximately two millimeters and ten millimeters. As can beappreciated, in an airway stent 300 configured for placement in thebronchioles, the length L2 of the distal region 304 may be smaller.

In the FIGS. 3A, 3B, and 3F, the airway stent 300 is depicted as havingan abrupt transition from the proximal region 302 to the distal region304. However, as can be appreciated, in other embodiments the transitionfrom the proximal region 302 to the distal region 304 may be gradual. Insome embodiments, the transition may be imperceptible. The proximalregion 302 may simply gradually flare distally. Moreover, the transitionfrom a circular cross-section of the proximal region 302 to anelliptical cross-section of the distal region 304 may be gradual andnearly imperceptible.

In the illustrated embodiment of FIGS. 3A-3F, the distal edge 320 of thedistal region 304 may be configured to have a planar configuration,meaning that the distal edge 320 may appear substantially flush orplanar (for example, relative to a plane orthogonal to the longitudinalaxis of the stent) when viewing the stent 300 from the side, such asanteroposteriorly or laterally. As appreciated, other configurations arepossible, as will be described below with reference to FIGS. 5A-5C and7A-7C.

The flare of the distal region 304 and/or the elliptical shape of thedistal edge 320 may serve as anti-migration features to secure the stent300 from proximal (toward the mouth) and/or distal migration (downdeeper into the airway). The stent 300, and in particular thescaffolding structure 301, may include additional anti-migrationfeatures. For example, one or more strut arms 324 may be slightly raisedabove (outward from) an outer circumference of the scaffolding structure301.

FIG. 4 is a cross-sectional view of the human lungs 100 and a sectionalview of the airway stent 300 of FIGS. 3A-3F positioned in the airway tostent the trachea 102 near the carinal region and/or the mainbifurcation junction 103. The main body 302 of the stent 300 is disposedwithin the trachea 102 and the distal region 304 flares and opens intothe main bifurcation junction 103. The distal region 304 is disposed inthe main bifurcation junction 103 above (proximal to) the carina 114 andbetween the right bronchus 104 and the left bronchus 106.

Presently available airway stents are delivered or deployed using arigid bronchoscope. The rigidity, size, shape, and/or configuration of abronchoscope prevent deployment of presently available airway stentsdeeper than the main bifurcation junction (or the tracheal bifurcationjunction) at the carina 114. Moreover, presently available stents forstenting a bifurcation junction are Y-shaped (with a bifurcated lumen)and must be deployed by a rigid bronchoscope, and thus cannot bedeployed distal to the carina 114 and/or the bronchi 104, 106. Bycontrast, the disclosed embodiments may be configured to be deployedwith a deployment mechanism that can be guided over a guide wire.Accordingly, the embodiments of the present disclosure can be deployedalmost anywhere a guide wire can be positioned within the lungs,including bifurcation junctions of the main bronchi 104, 106 and/orbifurcation junctions distal to the main bronchi 104, 106.

FIG. 4B is a sectional view of the human lungs 100 with an airway stent300 b positioned at left bronchus bifurcation junction 107 at a distalend of the left main bronchus 106. In FIG. 4B, guide wire 402 is shown,which may be used in positioning and/or guiding a tubular member 404 ofa deployment apparatus into the airway to a desired target location. Thetubular member 404 is illustrated in FIG. 4B advanced down the trachea102 over a portion of the guide wire 402. A flared portion of the stent300 b is positioned in the bifurcation junction where the left mainbronchus 106 branches into secondary bronchi 108. The stent 300 b ispositioned proximal to the bronchioles 110.

FIG. 4C is a sectional view of the human lungs 100 with an airway stent300 c positioned at a location distal to the left main bronchus 106.More specifically, the airway stent 300 c is deployed within a branch ofthe airway at a bifurcation junction 412 that is distal to the leftbronchus bifurcation junction 107 located at a distal end of the leftprincipal bronchus 106 of the airway. The airway stent 300 c may bedeployed within bronchi 108 and/or bronchioles 110 that branch intobronchioles 110. As noted above, the embodiments of the presentdisclosure can be deployed almost anywhere a guide wire can bepositioned within the lungs, including bifurcation junctions relativelydeep within the airway and far distal to the main bronchi 104, 106 andthe main bifurcation junction 103.

FIGS. 5A-5C illustrate an airway stent 500, according to anotherembodiment of the present disclosure. The airway stent 500 may include adistal region 504 with a convex configuration, meaning that the distaledge 520 of the distal region 504 may appear convex when viewedanteroposteriorly from the side. FIG. 5A is a side elevation view of theairway stent 500 viewed anteroposteriorly. FIG. 5B is a perspective viewof the airway stent 500 of FIG. 5A. FIG. 5C is another perspective viewof the airway stent 500 of FIG. 5A.

The stent 500 of FIGS. 5A-5C may resemble the stent 300 described abovewith respect to FIGS. 3A-3F. Accordingly, like features may bedesignated with like reference numerals, with the leading digitsincremented to “5.” Relevant disclosure set forth above regardingsimilarly identified features thus may not be repeated hereafter.Moreover, specific features of the stent 500 may not be shown oridentified by a reference numeral in the drawings or specificallydiscussed in the written description that follows. However, suchfeatures may clearly be the same, or substantially the same, as featuresdepicted in other embodiments and/or described with respect to suchembodiments. Accordingly, the relevant descriptions of such featuresapply equally to the features of the stent 500. Any suitable combinationof the features and variations of the same described with respect to thestent 300 can be employed with the stent 500, and vice versa. Thispattern of disclosure applies equally to further embodiments depicted insubsequent figures and described hereafter.

Referring collectively to FIGS. 5A-5C, the airway stent 500 includes aproximal region 502 (or a mid-body) and a distal region 504 (or a flaredregion). A non-bifurcated single lumen 530 may be defined through theairway stent 500. The airway stent 500 may be formed of a suitablematerial configured in a scaffolding structure 501 (only partiallydepicted for simplicity). The scaffolding structure 501 may form ordefine at least a portion of the mid body 502 and/or the distal region504. The scaffolding structure 501 may form a hollow, substantiallycylindrical shaped tube (although one or more cross-sectional diametersof the tube may vary independently as will be described below). Thescaffolding structure 501 may be constructed of a memory material, suchas Nitinol®, including ASTM F2063.

As illustrated in FIGS. 5A-5C, the scaffolding structure 501 may beformed of multiple annular segments, similar to the annular segments 322of the stent 300 shown in FIGS. 3A-3F and described above with respectto the same. However, the scaffolding structure 501 may include annularsegments that may be interconnected to one or more adjacent annularsegments by a plurality of connectors, or otherwise directlyinterconnect, to form diamond-shaped cells.

As mentioned above, the distal region 504 of the airway stent 500 mayhave a convex configuration. The airway stent 500 having the distalregion 504 in a convex configuration may be positioned in a bifurcationjunction of an airway differently than an airway stent having a planarconfiguration, such as the stent 300 of FIGS. 3A-3F and 4. Inparticular, than the left side 514 and right side 516 of the distal edge520 of airway stent 500 may sit more proximal (or higher, with lessdepth) in the airway than the corresponding left side 314 and right side316 of the distal edge 320 of airway stent 300, which has a planarconfiguration.

The left side 514 and right side 516 of the distal region 504 of theairway stent 500 may form and/or comprise lateral support regions. Thedepth of these lateral support regions within the airway may bedependent on the concavity or convexity of the distal region 504. When atumor is positioned substantially down a branch of a bifurcationjunction, for example on a wall opposite the carina 114 (or analogousridge-like structure of another bifurcation junction), positioning thelateral support regions more distal may be desirable. In other words, anairway stent having a planar configuration, such as the airway stent 300of FIGS. 3A-3F and 4, or an airway stent having a convex configuration,such as the airway stent 700 of FIGS. 7A-7C and 8, which is describedmore fully below, may better perform a desired stenting function ortreatment.

By contrast, the anatomy of a patient may be such that the branches of atarget bifurcation junction (i.e., the bifurcation junction to bestented) may branch at a relatively high angle. As a result, thebranches may be partially occluded by lateral support regions positionedtoo deeply in the target bifurcation junction. Accordingly, a convexconfiguration may be desirable to maintain or preserve patency of theairway.

FIG. 6 is a partial sectional view of the airway stent of FIGS. 5A-5Cpositioned in an airway to stent the trachea 102 at or near the carinalregion and/or the main bifurcation junction 103. The main body 502 ofthe stent 500 is disposed within the trachea 102 and the distal region504 flares and opens into the main bifurcation junction 103. Asillustrated in FIG. 6, the left and right sides 514, 516, or lateralsupport regions, of the distal region 504 are positioned high against anupper surface of the main bifurcation junction 103, thereby avoidingocclusion of the right and left bronchi 104, 106. The distal region 504is disposed in the main bifurcation junction 103 above (proximal to) thecarina 114 and between the right bronchus 104 and the left bronchus 106.

As can be appreciated, a variety of configurations of the distal regionare possible to provide varying lateral support while avoidingunnecessary occlusion of the branches of a bifurcation junction of anairway.

FIGS. 7A-7C illustrate an airway stent 700, according to anotherembodiment of the present disclosure. The airway stent 700 may include adistal region 704 with a concave configuration, meaning that the distaledge 720 of the distal region 704 may appear convex when viewedanteroposteriorly from the side. FIG. 7A is a side elevation view of theairway stent 700. FIG. 7B is a perspective view of the airway stent ofFIG. 7A. FIG. 7C is another perspective view of the airway stent of FIG.7A.

The stent 700 of FIGS. 7A-7C may resemble the stent embodimentsdescribed above. Accordingly, like features may be designated with likereference numerals, with the leading digits incremented to “7.” Relevantdisclosure set forth above regarding similarly identified features thusmay not be repeated hereafter. Moreover, specific features of the stent700 may not be shown or identified by a reference numeral in thedrawings or specifically discussed in the written description thatfollows. However, such features may clearly be the same, orsubstantially the same, as features depicted in other embodiments and/ordescribed with respect to such embodiments. Accordingly, the relevantdescriptions of such features apply equally to the features of the stent700. Any suitable combination of the features and variations of the samedescribed with respect to the previously disclosed stents can beemployed with the stent 700, and vice versa. This pattern of disclosureapplies equally to further embodiments depicted in subsequent figuresand described hereafter.

Referring collectively to FIGS. 7A-7C, the airway stent 700 includes aproximal region 702 (or a mid-body) and a distal region 704 (or a flaredregion). A non-bifurcated single lumen 730 may be defined through theairway stent 700. The airway stent 700 may be formed of a suitablematerial configured in a scaffolding structure 701 (only partiallydepicted for simplicity). The scaffolding structure 701 may form ordefine at least a portion of the mid body 702 and/or the distal region704. The scaffolding structure 701 may form a hollow, substantiallycylindrical shaped tube (although one or more cross-sectional diametersof the tube may vary independently as will be described below). Thescaffolding structure 701 may be constructed of a memory material, suchas Nitinol®, including ASTM F2063.

As illustrated in FIGS. 7A-7C, the scaffolding structure 701 may beformed of multiple annular segments, similar to the annular segments 322of the stent 300 shown in FIGS. 3A-3F and described above with respectto the same. However, the scaffolding structure 701 may include annularsegments that may be configured to interconnect to one or more adjacentannular segments by a plurality of connectors, or otherwise directlyinterconnect in a helical pattern.

The scaffolding structure 701 may comprise one or more rows of strutarms (e.g., annular segments) arranged and interconnected in a series ofturns to form a helix or helical pattern that wraps or winds around thelongitudinal axis A_(L) of the stent 700. The helical pattern of strutarms may be disposed on a circumference and may define at least aportion of the generally cylindrical shape of the scaffolding structure301. As can be appreciated, in some embodiments, the entire length ofthe stent 300 may comprise a helical pattern of interconnected strutarms. In other embodiments, however, only a portion of the stent 700,for example, a proximal zone or a transition zone, may comprise ahelical pattern. The helical pattern may be right-handed or left-handeddepending on which direction the one or more rows of strut arms wraparound the longitudinal axis A_(L).

The helical pattern may comprise a row of strut arms arranged to form azigzag pattern, defining alternating “peaks” and “valleys,” that maywrap around the longitudinal axis A_(L) of the stent 700. In someembodiments, the “peaks” and “valleys” on a row of strut arms may becoupled by connectors. In particular, the “peaks” on one turn of thehelical pattern may be coupled to the “valleys” on an adjacent turn ofthe helical pattern via connectors. As used herein, a “turn” of thehelical pattern refers to a segment of strut arms that wraps 360 degreesaround the longitudinal axis A_(L) of the stent 700. Adjacent turns ofthe helical pattern may adjoin each other at an end.

The helical pattern may wrap around the longitudinal axis A_(L) of thestent 700 at an angle. The angle may vary and may affect the structuralproperties of the stent 700. In some embodiments, the angle may remainsubstantially constant throughout the helical pattern. In otherembodiments, however, the angle may vary throughout the helical pattern.

As mentioned above, the distal region 704 of the airway stent 700 mayhave a concave configuration. The airway stent 700 having the distalregion 704 in a concave configuration may be positioned in a bifurcationjunction of an airway differently than an airway stent having a planarconfiguration, such as the stent 300 of FIGS. 3A-3F and 4, anddifferently than an airway stent having a convex configuration, such asthe stent 500 of FIGS. 5A-5C and 6. In particular, the lateral sides(e.g., the left side 714 and right side 716) of the distal edge 720 ofthe airway stent 700 may sit more distal in the airway than thecorresponding lateral sides (e.g., left side 314, 514 and right side316, 516) of the distal edge 720 of the airway stent 700.

The left side 714 and right side 716 of the distal region 704 of theairway stent 500 may form and/or comprise lateral support regions. Thedepth of these lateral support regions within the airway may bedependent on the concavity or convexity of the distal edge of the distalregion 704. When a tumor or other occlusion is positioned substantiallydown a branch of a bifurcation junction, for example on a wall oppositethe carina 114 (or an analogous ridge-like structure of another targetbifurcation junction), positioning the lateral support regions moredistal may be desired. An airway stent having a concave configurationmay better perform a desired stenting function or treatment on moredistal occlusions.

FIG. 8 is a partial sectional view of the airway stent of FIGS. 7A-7Cpositioned in an airway to stent the trachea 102 at or near the carinalregion and/or the main bifurcation junction 103. The main body 702 ofthe stent 700 is disposed within the trachea 102. The distal region 704is disposed in the main bifurcation junction 103 above (proximal to) thecarina 114 and between the right bronchus 104 and the left bronchus 106.The distal region 704 flares and opens into the main bifurcationjunction 103. As illustrated in FIG. 8, the left and right sides 714,716, or lateral support regions, of the distal region 704 are positionedto extend deeper into the airway against an upper surface of the mainbifurcation junction 103, thereby providing stenting support at agreater depth into the right and left bronchi 104, 106.

As can be appreciated, a variety of configurations of the distal region704 are possible to provide varying lateral support while avoidingunnecessary occlusion of the branches of a bifurcation junction of anairway.

A variety of configurations of the distal region 704 are possible toprovide varying lateral support for an occlusion that is deeper into abifurcation junction of an airway. For example, the lateral supportregions may further include projections (or wing-like structures) thatextend further distally down the airway and provide more distal stentingsupport.

FIGS. 9A-9D illustrate an airway stent 900, according to anotherembodiment of the present disclosure. FIG. 9A is a side elevation viewof the airway stent 900. FIG. 9B is a perspective view of the airwaystent 900 of FIG. 9A. FIG. 9C is another perspective view of the airwaystent 900 of FIG. 9A. FIG. 9C is an end view of the airway stent 900 ofFIG. 9A.

The stent 900 of FIGS. 9A-9D may resemble the stent embodimentsdescribed above. Accordingly, like features may be designated with likereference numerals, with the leading digits incremented to “9.” Relevantdisclosure set forth above regarding similarly identified features thusmay not be repeated hereafter. Moreover, specific features of the stent900 may not be shown or identified by a reference numeral in thedrawings or specifically discussed in the written description thatfollows. However, such features may clearly be the same, orsubstantially the same, as features depicted in other embodiments and/ordescribed with respect to such embodiments. Accordingly, the relevantdescriptions of such features apply equally to the features of the stent900. Any suitable combination of the features and variations of the samedescribed with respect to the previously disclosed stents can beemployed with the stent 900, and vice versa. This pattern of disclosureapplies equally to further embodiments depicted in subsequent figuresand described hereafter.

Referring collectively to FIGS. 9A-9D, the airway stent 900 may includea proximal region 902 (or a mid-body) and a distal region 904 (or aflared region). A non-bifurcated single lumen 930 may be defined throughthe airway stent 900. The distal region 904 of the airway stent 900 mayinclude a pair of notches 917 in the distal edge 920 that may beconfigured to engage, for example, the carina 114 (see FIG. 10) of themain bifurcation junction 103 of the trachea 102 or analogouscartilaginous ridge in a more distal bifurcation junction of the airway.

The notches 917 may be positioned opposite each other on the anteriorside 910 and posterior side 912 of the distal region 904, as shown inFIG. 9D. The notches 917 may be substantially aligned to form anengagement region 918 at the distal edge 920. The notches 917 andresulting engagement region 918 can provide stability to the positioningof the airway stent 900 by limiting shifting of the stent toward theleft or right. The notches 917, by limiting shifting of the stent,reduce a risk that the airway stent 900 may partially occlude thebifurcation junction of the airway. Moreover, the airway stent 900 issubstantially secured in place on the carina 114 of the main bifurcationjunction 103 (see FIG. 10) or similar cartilaginous ridge of a moredistal bifurcation junction, and is thereby limited from migratingdistally down the airway. Stabilization of the airway stent 900 at or onthe carina 114 (or analogous structure) can provide lateral support forflare region 904 and allow improved stenting expansion to open anoccluded bifurcation junction or provide needed structural support of abifurcation junction.

FIG. 10 is a partial sectional view of the airway stent of FIGS. 9A-9Dpositioned in an airway to stent the trachea 102 at or near the mainbifurcation junction 103, which branches in to the right bronchus 104and the left bronchus 106. The main body 902 of the stent 900 isdisposed within the trachea 102. The distal region 904 is disposed inthe main bifurcation junction 103 above (proximal to) the carina 114 andbetween the right bronchus 104 and the left bronchus 106. The distalregion 904 flares and opens into the main bifurcation junction 103. Thenotches 917 of the distal region 904 are shown engaging thecartilaginous ridge of the bifurcation junction, which in FIG. 10 is thecarina 114 in the main bifurcation junction 103.

In another embodiment of an airway stent, a proximal end of the proximalportion may include a flared region. The flared region may besubstantially symmetrical. In one embodiment, the flared region at theproximal end may have a diameter that is between one millimeter and fourmillimeters larger than a diameter of the main-body of the proximalregion. The size and degree of the flare region at the proximal end maydepend on whether the airway stent is configured for placement in thetrachea, bronchi, or bronchioles. The proximal flared region may be afeature of any of the above disclosed embodiments.

The embodiments of the present disclosure may include radiopaque markersat a proximal end and/or a distal stent ends. The markers on the distalend of the stent may be paired at the lateral sides and/or the anteriorand posterior sides to aid a practitioner during deployment orientation.

The proximal end may include suture eyelets and/or a suture to aid withpurse-string and removal from the airway post deployment.

The examples and embodiments disclosed herein are to be construed asmerely illustrative and exemplary, and not a limitation of the scope ofthe present disclosure in any way. It will be understood to those havingskill in the art that changes may be made to the details of theabove-described embodiments without departing from the underlyingprinciples of the disclosure herein. For example, any suitablecombination of various embodiments, or the features thereof, iscontemplated. For example, any of the implantable devices disclosedherein can include a scaffolding structure of any of the otherembodiments (e.g., a pattern of strut arms and annular segments of anyone or more of the various other disclosed embodiments). As anotherexample, any of the stents can include a distal edge having any of aplanar configuration, a concave configuration, or a convexconfiguration. As another example, any of the stents may include notchesin the distal edge. Furthermore, although symmetries are present in theillustrated embodiments, some embodiments may be asymmetrical.

It is intended that the scope of the invention be defined by the claimsappended hereto and their equivalents.

What is claimed is:
 1. An airway stent, comprising: a proximal regionhaving a cylindrical shape with a first opening at a proximal end, thefirst opening having a diameter equivalent to a diameter of the proximalregion of the airway stent; a distal region extending from the proximalregion to a second opening at a distal end, the distal region flaringoutward such that the second opening has a transverse cross-section withan elliptical shape having a lateral diameter that is larger than ananteroposterior diameter; and a non-bifurcated single lumen that extendsfrom the first opening and through the proximal and distal regions tothe second opening.
 2. The airway stent of claim 1, wherein a transversecross-section of the non-bifurcated single lumen at a proximal end ofthe distal region is approximately circular.
 3. The airway stent ofclaim 1, wherein the anteroposterior diameter of the second opening islarger than an anteroposterior diameter of a transverse cross-section ofthe non-bifurcated single lumen at a proximal end of the distal region.4. The airway stent of claim 1, wherein the distal region flares outwardat a plurality of angles about a circumference of the distal region toconform to an upper surface of an anatomy of a target bifurcationjunction of an airway.
 5. The airway stent of claim 1, wherein thedistal region flares anteroposteriorly at a first angle and flareslaterally at a second angle.
 6. The airway stent of claim 1, wherein adistal edge of the distal region lies in a plane orthogonal to alongitudinal axis of the non-bifurcated single lumen.
 7. The airwaystent of claim 1, wherein a distal edge of the distal region is convexas viewed in an anteroposterior direction.
 8. The airway stent of claim1, wherein a distal edge of the distal region is concave as viewed in ananteroposterior direction.
 9. The airway stent of claim 1, wherein adistal edge of the distal region includes a first notch at an anteriorside and a second notch at a posterior side, wherein the first andsecond notches are configured to engage a cartilaginous ridge that runsanteroposteriorly between branches of an airway at a target bifurcationjunction.
 10. The airway stent of claim 1, further comprising ascaffolding structure forming at least a portion of at least one of theproximal region and the distal region and defining a portion of thenon-bifurcated single lumen through the airway stent, the scaffoldingstructure formed of a plurality of annular segments each comprising aplurality of interconnected struts with adjacent struts disposed atangles relative to each other around a circumference of the at least oneof the proximal region and the distal region, wherein the plurality ofannular segments are arranged in rows in a longitudinal direction of thecylindrical shape.
 11. The airway stent of claim 10, further comprisinga polymeric cover applied to and between the struts of the plurality ofannular segments, the polymeric cover defining an interior region withinthe scaffolding structure.
 12. The airway stent of claim 10, whereineach annular segment of the plurality of annular segments is coupled toan adjacent annular segment.
 13. The airway stent of claim 12, whereinthe scaffolding structure further comprises a plurality of connectorsextending between and interconnecting adjacent annular segments, theconnectors arranged in an alternating pattern, such that connectors thatare adjacent in the longitudinal direction are offset from each other ina circumferential direction.
 14. An implantable device to stent anairway at a bifurcation junction, the implantable device comprising: aproximal region having a cylindrical hollow tube shape defining aproximal portion of a non-bifurcated single lumen through theimplantable device, the non-bifurcated single lumen extending axiallyalong a longitudinal axis of the implantable device from a first openingat a proximal end of the implantable device to a second opening at adistal end of the implantable device; a distal region disposed at andextending from a distal end of the proximal region, the distal regionflaring distally and outwardly from the proximal region to the secondopening to define a distal portion of the non-bifurcated single lumenthrough the implantable device and to enlarge one or more diameters ofthe non-bifurcated single lumen at the second opening at the distal endof the implantable device; wherein the second opening of thenon-bifurcated single lumen of the implantable device, at the distal endof the distal region, has a transverse cross-section with an ellipticalshape having a first diameter and a second diameter transverse to thefirst diameter, the first diameter being larger than the seconddiameter, larger than a diameter of the first opening at the proximalend of the implantable device, and larger than a diameter of atransverse cross-section of the non-bifurcated single lumen at aproximal end of the distal region and at the distal end of the proximalregion.
 15. The implantable device of claim 14, wherein theanteroposterior diameter of the distal region is larger than ananteroposterior diameter of a transverse cross-section of thenon-bifurcated single lumen at a proximal end of the distal region. 16.The implantable device of claim 14, wherein the distal region flaresanteroposteriorly at a first angle and flares laterally at a secondangle.
 17. The implantable device of claim 14, wherein a distal edge ofthe distal region lies in a plane orthogonal to the longitudinal axis.18. The implantable device of claim 14, wherein a distal edge of thedistal region does not lie entirely in a plane orthogonal to thelongitudinal axis.
 19. The implantable device of claim 14, furthercomprising a scaffolding structure forming at least a portion of atleast one of the proximal region and the distal region and defining aportion of the non-bifurcated single lumen through the implantabledevice, the scaffolding structure formed of a plurality of annularsegments each comprising a plurality of interconnected struts withadjacent struts disposed at angles relative to each other around acircumference of the at least a portion of the at least one of thecylindrical shape of the proximal region and the distal region, whereinthe plurality of annular segments are arranged in rows in thelongitudinal direction of the cylindrical shape.
 20. A method ofstenting an airway of a patient at or near a bifurcation junction of alumen of the airway, the method comprising: obtaining an implantabledevice having a cylindrical shaped proximal region, a distal regiondisposed at a distal end of the proximal region, and a non-bifurcatedsingle lumen disposed through the implantable device; positioning adeployment apparatus within the airway at a desired position at or nearthe bifurcation junction, the deployment apparatus loaded with theimplantable device; deploying the implantable device from the deploymentapparatus; and positioning the distal region of the implantable devicewithin the bifurcation junction of the lumen of the airway.
 21. Themethod of claim 20, wherein a distal opening of the non-bifurcatedsingle lumen of the implantable device, at a distal end of the distalregion, has a transverse cross-section with an elliptical shape having alateral diameter that is larger than an anteroposterior diameter, andwherein the method further comprises: orienting the distal region toalign the anteroposterior diameter in an anteroposterior directionwithin bifurcation junction.
 22. The method of claim 20, wherein thedistal region flares anteroposteriorly at a first angle and flareslaterally at a second angle, and wherein the method further comprises:orienting the distal region to align the first angle of outward flare ofthe distal region in an anteroposterior direction within bifurcationjunction.
 23. The method of claim 20, wherein a distal edge of thedistal region of the implantable device comprises a notch, and whereinthe method further comprises: aligning the notch to engage acartilaginous ridge of the bifurcation junction that runsanteroposteriorly between branches of the airway at the bifurcationjunction.
 24. The method of claim 23, wherein the cartilaginous ridge isa carina disposed between a left bronchus and a right bronchus at a mainbifurcation junction at a distal end of a trachea, and wherein aligningthe notch comprises engaging the carina within the main bifurcationjunction at a distal end of a trachea.
 25. The method of claim 20,wherein the bifurcation junction is disposed distal to one of a rightprincipal bronchus and a left principal bronchus of the airway.
 26. Themethod of claim 20, wherein the bifurcation junction is at a distal endof a branch of the airway that is located distal to a bifurcationjunction at a distal end of one of a right principal bronchus and a leftprincipal bronchus of the airway.
 27. The method of claim 20, furthercomprising: positioning a guidewire within the airway to a desiredposition at or near the bifurcation junction, wherein positioning thedeployment apparatus within the airway comprises advancing thedeployment apparatus, including the implantable device, over theguidewire.